INTERNATIONAL TOBACCO AND HEALTH RESEARCH AND CAPACITY BUILDING PROGRAM
Release Date: June 25, 2001
RFA: RFA-TW-02-005 (This RFA has been reissued, see RFA-TW-06-006)
Fogarty International Center
(http://www.nih.gov/fic/)
National Cancer Institute
(http://www.nci.nih.gov/)
National Institute of Child Health and Human Development
(http://www.nichd.nih.gov/)
National Institute of Mental Health
(http://www.nimh.nih.gov/)
National Institute of Nursing Research
(http://www.ninr.nih.gov/)
National Institute on Drug Abuse
(http://www.nida.nih.gov/)
Letter of Intent Receipt Date: September 4, 2001
Application Receipt Date: October 26, 2001
PURPOSE
This Request for Applications (RFA) solicits research and capacity building
projects that address the burden of tobacco consumption in low- and middle-
income nations by 1) pursuing observational, intervention and policy research
of local relevance and 2) building capacity in these regions in
epidemiological and behavioral research, prevention, treatment,
communications, health services and policy research. The level of research
and research training specialization in any given research project grant will
vary based on the strengths of the particular investigators and institutions
that apply and the need to build capacity to support research and future
interventions. The overall intent of the program is to encourage
transdisciplinary approaches to the international tobacco epidemic to reduce
the global burden of tobacco-related illness. The program is designed to
promote international cooperation between investigators in the U.S. and other
high-income nation(s) pursuing research programs on tobacco control, and
scientists and institutions in low- and middle-income nation(s) where tobacco
consumption is a current or anticipated public health urgency. The major
portion of the research must be conducted in a low- and/or middle-income
nation(s), and greater than 50 percent of the direct costs requested must be
used in a low- and/or middle-income nation(s) or “in-country” for either
research and/or capacity strengthening of foreign institutions. Thus, the
program allows U.S. and other high-income nation investigators to gain
expertise working under low- and middle-income nation-specific conditions and
strengthens the research base of the U.S. and foreign institution(s),
especially those institutions in low- and middle-income nations. To this end,
capacity strengthening must be integrated into the research proposal. In this
RFA, the term “tobacco” includes both smoking and smokeless (chewing or
unburned) tobacco.
RESEARCH OBJECTIVES
Background
Despite the continuing devastation caused by infectious diseases, tobacco
consumption remains the leading cause of preventable deaths and disability in
adults globally. As cited by the World Health Organization (WHO), at present,
seven and one half percent of the world's 53 million annual deaths are
attributable to tobacco use. If current smoking patterns persist, the number
of tobacco deaths will rise to ten million deaths annually by 2025, surpassing
the combined deaths of AIDS, tuberculosis, automobile accidents, maternal
mortality, homicide and suicide. Notably, 70 percent of this increase will
occur in developing nations.
The WHO has termed tobacco control the quintessential challenge of sustainable
development, since it carries implications for trade and taxation,
agricultural subsidies, the environment, social policies, and health care
expenditures, among other sectors. Blunting the epidemic requires a better
basic understanding of the addictive properties of nicotine, including the
manifestations, determinants and outcomes of dependence for the individual and
society. While aware that the complications of nicotine risks and tobacco
exposure in low- and middle-income countries may be distinct or different from
those in high-income nations, this RFA is not directed at repeating research
that is already well-established.
Trends show that most smokers begin at a young age. In high-income nations,
about eight out of ten smokers begin in their teens, while most smokers in
low- and middle-income nations begin in their early twenties. The peak age of
tobacco uptake in low- and middle-income nations, however, is dropping. The
younger the smoker, the less likely the individual will quit at a later time.
Half of all long-term smokers will eventually be killed by tobacco, and of
these, half will die during their most productive middle years, losing 20 to
25 years of life. While the impact of tobacco mortality is well-studied in
established market economies, important questions remain unresolved in other
regions, particularly in low- and middle-income nations.
There is little research in low- and middle-income nations of the possible
interaction of smoking and shifting dietary patterns on the pathogenesis of
ischemic heart disease. Evidence clearly implicates Environmental Tobacco
Smoke (ETS) as a cause of lung cancer, excess respiratory disease and
cardiovascular disease mortality in non-smokers. Few studies document the
interactions of tobacco and occupational and ambient air pollution in
contributing to chronic obstructive pulmonary disorders in developing
countries, or the importance of ETS as a risk factor for the already high
burden of childhood respiratory infections. The disease burden of tobacco is
of such magnitude that even minor epidemiological differences among
populations may have major implications for control. There is also a dearth
of information on gender and age differences with respect to incentives and
disincentives for tobacco use and cessation.
According to the World Bank, in low- and middle-income nations, the prevalence
of smoking among women is low (nine percent), as compared to men (49 percent).
However, there is already evidence that this index is rising, particularly
among younger, educated, affluent women living in larger cities. An increased
prevalence among women will have grave consequences not only for the health of
women, but also their families. Research is needed to assist low- and middle-
income nations to maintain or, preferably, decrease the currently low
prevalence that exists among women, and to better understand how tobacco use
can be decreased within the family.
Two recent studies in the Journal of the American Medical Association focus on
the association of cigarette smoking with psychiatric disorders among
adolescents and young adults and the propensity to smoke if an individual has
a mental illness (1), (2). In low- and middle-income nations, studies are
needed to trace links between mental illness, smoking uptake and cessation
rate to better explain the unique health situation in low- and middle-income
nations, where links between mental illness and tobacco are rarely diagnosed.
Such studies would also provide an opportunity for investigators to learn
whether heavy smokers in low- and middle-nations are more likely to experience
mental illness as a result of tobacco use or whether individuals with mental
illness have a predilection towards tobacco use. Furthermore, little is known
about risk taking behavior among adolescents and young adults. In this group,
tobacco may be linked with other risk taking behaviors such as alcohol use,
drug abuse, unprotected sexual activity and reckless driving of vehicles, all
of which could have a unique profile in low- and middle-income nations.
Several countries have begun to explore programs to prevent and treat tobacco
use and dependence, but the data are sparse on the effectiveness of those
interventions. For example, data from the recent U.S. Public Health Service
Treatment Guideline, Treating Tobacco Use and Dependence, indicate that
telephone based “quitlines” may be effective and cost-effective (3). It is
unknown, however, whether such related approaches would work in low- and
middle-income nations. Within the U.S., a positive influence has been shown
from nurse researchers, nursing schools, and community health workers who
educate the public on tobacco prevention and cessation. Nurse investigators
have conducted a number of studies related to tobacco use and smoking
cessation. A recent study in the Journal of Community Health highlighted the
contribution of nurse researchers in identifying tobacco consumption variables
(i.e., demographic, cultural, cognitive, and behavioral factors and patterns
of consumption) among rural Ohio Appalachians (4). Findings from this study
are being used to develop effective smoking cessation interventions targeting
this high-risk population. Nurse investigators have contributed to the
growing body of research related to tobacco use and smoking cessation
interventions across the life span, primarily in the United States. However,
it is unknown whether international nursing research focusing on tobacco use
would help reduce the tobacco burden in low- and middle-income nations.
Finally, in those countries that have implemented policy-based controls,
including legislation, research is needed to assess the impact and
effectiveness of these measures.
This RFA is intended to support research that clarifies important issues on
tobacco consumption and risks that are relevant to low- and middle-income
nations. Such studies will provide a better understanding of the tobacco
burden in low- and middle-income nations and the possible actions and
interventions that may be taken to reduce the epidemic.
Statistical trends demonstrate the steady geographic shift in tobacco
production and consumption. In the early 1960s, low- and middle-income
nations constituted 53 percent of the world’s tobacco production; by the late
1980s, this share had expanded to almost 75 percent. Global consumption has
also increased. In the mid-1970s, 41 percent of the world's cigarettes were
consumed in the developing world. In the 1980s, total cigarette consumption
in these countries had increased to 60 percent. Tobacco use in low- and
middle-income nations is now considered to have reached 82 percent of global
consumption with a dramatic increase in local production.
In addition to the human costs associated with tobacco-related morbidity and
mortality, enormous economic costs are associated with tobacco use, including
medical care for treatment of tobacco-related diseases, absenteeism from work,
decreased productivity, losses due to fire, and lost income due to early
mortality. A 1993 World Bank study estimated that tobacco use results in a
global net loss of $200 billion per year, half of which occurs in low- and
middle-income nations (5). The impact of tobacco related losses on the world
economy exceeds the total current health expenditures in all developing
countries combined.
Individuals spend significant personal and household income to support their
tobacco use. Expenditures on tobacco products can be as much as 17 percent of
household income and 60 percent of personal income. Some governments are
hesitant to curtail tobacco production and may be diffident towards aggressive
tobacco controls, since they can draw significant revenue from excise taxes
and exportation. Furthermore, most tobacco reporting lacks data to
substantiate the magnitude of the international tobacco epidemic and the
effectiveness of interventions.
Much of the available research on tobacco control is based on the experiences
of established market economies. This research is only partially relevant to
the social, economic, and cultural climate in many low- and middle-income
nations. Recent epidemiological data from Brazil, India, South Africa, and
the Republic of China allows for more accurate projections of other low- and
middle-income nations than those previously attempted with data from high-
income nations. The implication of these trends for morbidity, mortality and
lost productivity is enormous because tobacco control research capacity in
low- and middle-income nations is severely circumscribed.
Evidence from the World Bank Report, Curbing the Epidemic, shows that price
increases, particularly through increased taxes, advertising bans and counter-
advertising, and ETS restrictions have a measurable impact to decrease smoking
(6). These factors are likely to require measures to change behaviors, reduce
the initiation of smoking and use of smokeless tobacco products, specifically
in youth and adolescents, and enhance permanent cessation by those addicted to
nicotine. Behavior change is favored when context-specific causes and
motivations are understood. Policy change is favored when committed
individuals in leadership positions have relevant information available to
them, especially information showing economic gain from policy changes.
Ideally, a variety of research will be conducted since a single strategy is
unlikely to suffice for most low- and middle-income nations.
Progress in global tobacco control will depend upon standardized and
comparable surveillance data; international research networks and information;
and heightened capacity for tobacco control research among developing nations.
In recent years, there have been a number of reviews to identify international
tobacco control research needs. In 1998, the Institute of Medicine’s Board on
Global Health outlined research needs in a report on cardiovascular disease
prevention (http://www.nap.edu/catalog/6218.html). Also in 1998, a working
group was convened at the 10th World Conference on Tobacco or Health to
identify research fields and public health data with the highest potential to
affect tobacco control policy. The Research for International Tobacco Control
(RITC) group, hosted by the Canadian International Development Research Centre
convened regional workshops in the Caribbean, Southeast Asia and Sub-Saharan
Africa to outline regional agendas. In 1999, the World Bank produced Curbing
the Epidemic, a monograph on the economics of tobacco control, including areas
of needed research. These analyses have been instrumental to the development
of this RFA.
The goal of this RFA is to solicit applications for hypothesis testing and
hypothesis generating studies, and to train low- and middle-income nation
investigators who will examine the manifestations, determinants and outcomes
of tobacco use, including smokeless tobacco products, and evaluate
interventions in a range of areas.
Scientific Objectives
1. Research: This RFA encourages trans-disciplinary research. Applications
may address one or more of the provided categories of research. Both research
and capacity strengthening must be included in the application. Categories of
research may include, but are not necessarily limited to, the following
activities:
a) Epidemiological and Surveillance Research: A broad spectrum of
epidemiological and surveillance research may be pursued to enhance the
knowledge of tobacco-related health problems and risks relevant to low- and
middle-income nations.
o Characterize the prevalence and trends of tobacco initiation, use and
consumption patterns, including oral tobacco use, particularly to identify
high-risk groups;
o Describe patterns and trends in tobacco-attributable morbidity and
mortality;
o Document and monitor trends in the nature, extent, and patterns of co-
occurring tobacco and drug use and/or abuse (including polydrug use) and drug-
related behavioral and social consequences in general and in special
populations, especially in youth, adolescents and young adults; and
o Determine tobacco’s effect on responses to other abused drugs, including
the inclination to self-administer.
b) Susceptibility and Risk: Examine the differences of tobacco initiation,
consumption and cessation by gender, ethnicity, culture, income and education
relevant to low- and middle-income nations.
o Identify susceptibility factors that initiate tobacco use and prompt
tobacco dependence, including gender, ethnicity, culture, income and
education, to better characterize high-risk individuals and populations.
Develop new targets for interventions;
o Examine differential rates of tobacco addiction and their association with
factors such as nicotine content and other product characteristics;
o Examine the potential interaction between ETS and occupational or ambient
air pollutants and local exposure in the pathogenesis of respiratory diseases,
including its effect on childhood respiratory diseases, Sudden Infant Death
Syndrome (SIDS), middle ear disease; and
o Identify biomarkers for quantitating human exposure to ETS in the home and
workplace and for predicting potential health risks for exposed individuals,
especially youth, adolescents and young adults.
c) Biobehavioral and Social Research: Behavioral and social research may
emphasize tobacco advertising and awareness, smoking uptake and quit rate, and
intervention strategies relevant to the cultural differences and needs of low-
and middle-income nations.
o Examine factors that influence positive and negative responses to
advertising, promotional, mass media, and warning messages aimed at
encouraging or discouraging tobacco use;
o Identify levels of awareness of health risks associated with tobacco
consumption among different segments of the population;
o Identify sociocultural, psychological, physiological and genetic factors
that influence smoking initiation and progression to nicotine addiction, and
smoking cessation in all populations, not only high risk groups;
o Examine co-morbid and medical disorders (e.g. depression, anxiety, heart
disease and cancer) associated with tobacco use. Identify risk and protective
factors for co-morbidity, and develop and test new intervention strategies;
o Examine tobacco use in mental illness, and the role of depression and other
psychiatric disorders in risk and relapse; and
o Analyze the meaning of “branding” (i.e. to mark as desirable) and tobacco
marketing images as determinants of tobacco uptake and continuance. Develop
interventions aimed at testing consumer reaction to plain packaging.
d) Intervention Research: Building on established intervention research
conducted in high-income nations, investigators may engage in studies that
examine different methods of tobacco control implementation and interventions
and that are appropriate to developing country needs, infrastructure and
resources.
o Evaluate prevention and treatment programs and sociocultural studies to
elucidate differences in responsiveness to interventions among different ages,
ethnic and racial groups, and gravid and non-gravid women;
o Examine the effectiveness and consequences of prevention interventions that
employ single-risk versus multiple-risk strategies, especially in youth,
adolescents, and young adults;
o Examine community-based interventions that have the potential to impact
large populations, such as those using evidence-based behavioral,
sociological, and communication methods;
o Evaluate new pharmaceutical or behavioral interventions and delivery
mechanisms, their cost-effectiveness and impact in diverse sociocultural,
physiological and genetic subgroups. Compare pharmaceutical interventions,
behavioral therapy and combination pharmaceutical and behavioral therapy in
children, adolescents, young adults, and gravid and non-gravid women;
o Examine the combined impact of tobacco control measures, (i.e. the “optimal
policy mix”) with respect to prevalence in different groups, especially in
children, adolescents, young adults, and gravid and non-gravid women; and
o Examine the effectiveness of various health service settings to assess
smoking rates, to prevent initiation and to promote quitting. In particular,
evaluate tobacco prevention and cessation education interventions of nurse
researchers, nurse practitioners, schools of nursing, community health
workers, and physicians.
e) Policy-Related Research: Policy-related research may examine current
tobacco control policy and enforcement, or lack thereof, in low- and middle-
income nations. Studies may also determine the impact of current and needed
tobacco control policies, regulations and trade on public health and the risk
factors associated with tobacco consumption relevant to low- and middle-income
nations.
o Assess the use of morbidity and mortality data and other information on the
development of government tobacco reduction policies;
o Examine the effectiveness of price increases, ETS restrictions, youth
access measures, advertising and marketing bans and restrictions, and
regulatory and legal approaches to reducing tobacco initiation and promoting
tobacco cessation;
o Examine the availability and effectiveness of the range of information,
advertising and marketing approaches to increase the cessation rate in study
populations;
o Encourage research on the effect of counter-advertising and stigmatizing
tobacco use, including smokeless tobacco, on uptake and sustained tobacco use
by different age and gender groups, especially in youth, adolescents and young
adults;
o Assess the long-term health and economic implications of failure to control
future tobacco-related health efforts; and
o Examine the political economy of tobacco control and its impact on health.
2. Capacity and Infrastructure Strengthening: A strategic goal of this RFA
is to strengthen capacity and infrastructure within low- and middle-income
nations. Capacity building and infrastructure strengthening promote the
advancement of research and the enhancement of the number and the knowledge of
tobacco investigators in low- and middle-income nations. A long-term outcome
of capacity and infrastructure strengthening is the ability to augment
scientific competence and skills nationally and internationally, and develop a
cadre of tobacco researchers with proper research training and support who
will continue to carry out tobacco control research in a low- and middle-
income nation(s). Capacity and infrastructure strengthening provide important
opportunities for investigators from high-income nations to gain knowledge of
and experience in tobacco control issues of both high-income and low- and
middle-income nations. Capacity strengthening provides investigators in low-
and middle-income nations with the skills and infrastructure to expand and
enhance their work in tobacco control research. Capacity strengthening is a
requirement of this RFA. Applicants should address the following:
o Support research training of faculty to meet the goals of the proposed
research as well as the needs of the low- and/or middle-income nation(s).
Capacity strengthening will focus on the outcomes of tobacco consumption, and
evaluation of public health and policy interventions relevant to the low-
and/or middle-income nation(s). This research training will provide
opportunities to augment field experiences and perspectives of investigators
from low- and/or middle-income nations. Collaborations should extend or
enhance in a mutually beneficial manner the tobacco control research interests
of the principal and co-investigators. At the same time, the potential
capacity of the low- and/or middle-income nation investigator and institution
should increase to provide sustainable and productive behavioral, intervention
and policy research capacity, which will address the tobacco burden in the
participating low- and/or middle-income nation(s);
o Promote institutional strengthening in tobacco control research through
support for and linking of relevant departments or institutions working on
tobacco-related scientific research;
o Encourage research training opportunities for low-and middle-income nation
investigators, including long-term research training as part of the research,
practical and applied short-term courses and workshops “in-country” for
professionals or technicians; and course work, laboratory or field research
training in essential research skills for technical assistants, graduate
degree candidates, or other health professionals;
o Promote the advancement of tobacco control-related training for tobacco
control investigators and health professionals from low- and/or middle-income
nation(s) by career enhancement and institutional capacity strengthening in
low- and/or middle income nations. The research grants funded from this RFA
will provide research training for individuals considered associated with an
institution and designated as “Research Associates.” This research training
should not be confused with National Research Service Award (NRSA) support,
where trainees do not have an employee-employer relationship. The following
types of training may be included: long-term (more than nine months and up to
three years) research training in pre- or post-doctoral programs; short-term
(less than three months) research training (could encompass workshops focused
on program and grants administration, technology transfer, protocol
development of projects, and data management and analysis); intermediate-term
research training (could include specialized activities in support of tobacco
control research). The emphasis for research training for this RFA will be on
intermediate to longer-term training, including mid-career training. This
approach will accelerate building an enduring tobacco control research
environment, facilitate the adoption of tobacco control policies, and
strengthen public health capacity at foreign “in country” sites;
o Post-doctoral and degree candidates must be listed as research associates
on PHS application form 398, page DD, and would be considered as having an
employee-employer relationship. Salaries, tuition remission, and other forms
of compensation paid as, or in lieu of, wages to degree candidates or post-
doctoral trainees to conduct research related to the goals of this RFA are
allowable. Costs and plans must be included in the text of the proposal and
reflected in the proposal's budget;
o Enhance low- and/or middle-income nation(s) investigators’ observational,
intervention and policy research on tobacco control by promoting
multidisciplinary approaches to research training. Institutional capacity
strengthening could encompass basic, social and behavioral sciences,
economics, community-based research, and legal studies. Using resources
available under this award, applicants could broaden their knowledge of
tobacco-related disease or illnesses with courses related to polydrug abuse,
cardiovascular disease and cancer control and prevention. An example of an
appropriate curriculum would be a course concentrating on the principles and
practice of cancer prevention and control, with discussions on a range of
issues, including genetics and cancer biology, and behavioral science and
community interventions (http://dcp.nci.nih.gov/pob/courses/index.html);
o Promote clinical, operational and health services research on the effects,
risk assessment and risk reduction related to tobacco use;
o Support tobacco-related institutional infrastructure development and
research training in bioethics, informatics, economics and other crosscutting
disciplines; and
o Support the development of “in-country” tobacco control infrastructure at
the institution, academic, and Non-Governmental Organization (NGO) level,
including laboratory and field research on a country- and project-specific
basis.
SPECIAL REQUIREMENTS
Collaborations
This program is intended to generate useful scientific information and promote
collaboration between investigators and institutions in the United States or
other high-income nations and low- and middle-income nations with shared
interests in reducing the consequences of tobacco consumption. To achieve
this, research and capacity strengthening may reflect new or on-going
activities and may demonstrate a collaboration between a Principal
Investigator (PI) (U.S. or other high-income investigator(s)) and a co-
investigator(s) from a low- and/or middle-income nation(s). If the PI is from
a low- or middle-income nation, the proposal will be developed jointly by the
PI and one from the U.S. or other high-income nation. Collaboration between
the foreign investigator and a U.S. investigator(s) is highly encouraged.
Research findings must be relevant to the collaborating low- and/or middle-
income nation(s). (For operational and analytic purposes, the World Bank’s
main criterion for classifying economies, gross national product per capita,
will be employed for this RFA to determine eligibility. A list of countries
representing low- and middle-income economies, which are eligible for this
program may be found at http://www.worldbank.org/data/countryclass/
classgroups.htm). Interdisciplinary approaches to examining the dynamics
of tobacco consumption are especially encouraged. Advances are most likely
to be achieved through interdisciplinary collaborations (i.e. economics,
epidemiology, demography, anthropology, sociology, communications, behavioral
science, basic biological sciences, psychology and pediatrics).
Co-Sponsors
This RFA is co-sponsored by WHO’s Tobacco Free Initiative
http://tobacco.who.int/. The WHO Collaborating Centres are eligible and
encouraged to apply for funding under the terms of reference of this RFA and
other applicants are encouraged to apply in conjunction with WHO Collaborating
Centres http://tobacco.who.int/en/tfi/radvisers.html. The WHO will
participate in the annual network meeting of awardees, co-funding agencies,
and selected international tobacco researchers outlined in this RFA.
Establishing Research Priorities
The applicant should demonstrate that the research proposed relates to the
burden of tobacco and reflects the priorities of the low- and/or middle-income
collaborating nation(s) and should describe in detail the procedures to ensure
that both research and research training reflect these priorities.
Strategy for Regional Impact
The applicant should emphasize tobacco control capacity building at the
collaborating foreign institution(s) and in low- and/or middle-income nations.
The applicant should describe in detail strategies and specific activities to
achieve a wider regional impact. This will occur by strengthening other
institutions and/or international organizations in the low- and/or middle-
income nation(s) and/or in neighboring countries, with the long-term strategic
goals of disseminating and educating the public on tobacco control and policy
and building a regional center. The program would offer training on tobacco
research and control to other areas and countries consistent with regional
resources.
National Support for the Program
Letters of support for the proposed research and capacity strengthening
program from the collaborating foreign academic and governmental
institution(s) must be submitted with the application. Evidence should be
provided in writing of national support for the program through cost-sharing,
(e.g.. supplies, funds, salaries, equipment, laboratory space, personnel,
etc.) support by the host country, and willingness of the foreign government
to utilize investigators’ experience and knowledge gained from the program to
build policy and initiatives in tobacco control and research, and capacity
strengthening. This could be done, for example, through a regional or
national research-training center in the collaborating foreign country
supported by the program. Note that cost-sharing funds will be subject to NIH
cost-accounting rules. Additionally, NIH hopes that the research and training
funded through this RFA will have a long-term positive impact to reduce
tobacco use in low- and middle-income nations. NIH hopes that collaborating
low- and/or middle-income nations(s) will utilize the expertise of those who
receive research training under this RFA; that, following their training,
trainees will be able to return to the host country and assume positions of
responsibility in research and/or public health in tobacco control and
prevention. For this reason, the review process will include the criteria of
sustainability: whether or not an application demonstrates the ability to
sustain and utilize the research and training provided through this RFA after
the completion of the grant period.
Continued Collaboration
Descriptions of plans for continued collaboration with foreign collaborators
and investigators once trainees return home must be included in the
application, including strategies for continued mentoring of trainees and
tracking career paths of trainees after they have returned home. Tracking of
short- and long-term research training and other institutional capacity
strengthening, including mentoring, will be done by a web-based reporting
system, Annual Reports and through other means.
Assurances
Before an award will be made, the grantee institution must show written
evidence of formal approval (assurances) from responsible authorities at the
collaborating institution, from an institutional (or ethical) review board or
committee at both the U.S. and foreign institution(s) and from the relevant
government authority. Please see “Procedures for Registering Institutional
Review Boards and Filing Federal wide assurances of Protection for Human
Subjects (FWAs)” http://www.hhs.gov/ohrp/assurances/assurances_index.html.
Annual Meetings
There will be periodic annual network meetings of awardees, co-funding
agencies, and selected international tobacco researchers in Bethesda, MD.
Those receiving awards will be expected to participate in these meetings
(generally one annual two-day meeting). The purpose of these meetings will be
to exchange and benefit from research and research-training experiences and to
coordinate program activities. In Year One, PIs should budget for themselves
and their co-investigator(s) to attend the annual network meeting. In
subsequent years, PIs should budget for themselves, their co-investigator(s)
and two to three other project personnel (selected trainees and/or program
administrators) to attend. Funds for this two-day activity (travel, lodging,
and per diem) should be included in the budgetary requests. Consideration
will be given to holding annual network meetings in developing countries when
this would provide benefits to those persons and be cost-effective.
Inclusion of Student and Postdoctoral Research Assistants/Associates
Post-doctoral and degree candidates must be listed as research associates on
PHS application form 398, page DD, and would be considered as having an
employee-employer relationship. Salaries, tuition remission, and other forms
of compensation paid as, or in lieu of, wages to degree candidates or post-
doctoral trainees to conduct research related to the goals of this RFA are
allowable. Costs and plans must be included in the text of the proposal and
reflected in the proposal's budget.
Dissemination
All applications should include a detailed discussion of a) how the results of
the research being proposed can be rapidly disseminated and adopted on a large
scale and b) why the results of the research being proposed, if disseminated
and adopted on a large scale, could have a significant effect on the reduction
of tobacco use in the community, host country or region.
RESEARCH INVOLVING HUMAN SUBJECTS
If the proposed research involves human subjects, applicants must inform the
Fogarty International Center program staff that approval of research protocols
involving human subjects has been obtained from U.S. and developing country
institutional review boards and required U.S. and foreign government agencies
before an award will be made.
MECHANISM OF SUPPORT
This RFA will use the National Institutes of Health (NIH) individual research
grant (R01) award mechanism. Responsibility for the planning, direction and
management of the proposed project will be that of the Principal Investigator
in consultation with their co-investigator(s). A Principal Investigator may
request a project period of up to five years and a budget for direct costs of
up to $400,000 per year.
FUNDS AVAILABLE
It is expected that approximately $3.5 million per year in total costs (direct
costs plus facilities and administrative (F & A) costs) from all supporting
collaborating NIH Institutes and Centers will be available for up to five
years, beginning in fiscal year 2002, to fund an estimated six to eight new
grants in response to this RFA. This support is dependent upon the receipt of
a sufficient number of applications of high scientific merit. Although this
program is provided for in the financial plans of the participating Institutes
and Centers, awards are contingent upon the availability of funds from FIC and
collaborating partners for this purpose and the receipt of a sufficient number
of meritorious applications.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state and local governments, and eligible
agencies of the Federal government. This RFA is open to all qualified
investigators. Principal Investigators from the U.S. or other high-income
nation(s) are required to collaborate with an investigator(s) from a low-
and/or middle-income nation(s). Principal Investigators from a low- and/or
middle-income nation are strongly encouraged to collaborate with a U.S. and/or
other high-income nation(s). Racial/ethnic minority individuals in the U.S.,
women, and persons with disabilities are encouraged to apply as PIs.
All current policies and requirements that govern the research grant programs
of the National Institutes of Health (NIH) will apply to grants awarded under
this RFA. Awards under this RFA to foreign institutions will be made only in
accordance with NIH policy governing such awards.
INQUIRIES
Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
FIC
Joel Breman, M.D., D.T.P.H.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-2516
Fax: (301) 402-0779
Email: bremanj@mail.nih.gov
NCI
Michele Bloch, M.D., Ph.D.
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Plaza Blvd., Room 4032
Bethesda, MD 20892
Phone: (301) 496-8584
Fax: (301) 496-8675
Email: blochm@mail.nih.gov
NICHD
Lynne Haverkos, M.D., M.P.H.
Center for Research for Mothers and Children (CRMC)
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05B
Bethesda, MD 20892-7510
Telephone: (301) 435-6881
Fax: (301) 480-7773
Email: haverkol@mail.nih.gov
NIMH
Peter Muehrer, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health, National Institutes of Health
6001 Executive Boulevard, Room 6189, MSC 9615
Bethesda, MD 20892-9615
Telephone: (301) 443-4708
Fax: (301) 480-2920
Email: pmuehrer@mail.nih.gov
NINR
Janice Phillips, Ph.D., RN, FAAN
National Institute of Nursing Research
Building 45, Room 3AN12
45 Center Drive, MSC 6300
Bethesda, MD 20892-6300
Telephone: (301) 594-6152
Fax: (301) 480-8260
Email: phillipsj@mail.nih.gov
NIDA
Steve Gust, Ph.D.
International Program
National Institute on Drug Abuse
6001 Executive Blvd., Room 5274
Bethesda, MD 20892
Telephone: (301) 443-6480
Fax: (301) 443-9127
Email: sgust@mail.nih.gov
Programmatic inquiries can also be addressed to the NIH program contacts
listed on the FIC web site (http://www.nih.gov/fic/programs.html) for the
International Tobacco and Health Research and Capacity Building Program.
Frequently asked questions and responses to these inquiries will also be
listed at this web site.
Direct inquiries regarding review issues to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8326
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8326
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: friedbet@mail.nih.gov
Direct inquiries regarding fiscal matters to:
Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, Maryland 20892-2220
Telephone: (301) 496-1670
Fax: (301) 594-1211
Email: butrumb@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit, by September 4, 2001, a Letter of
Intent that includes a descriptive title of the proposed research, the name,
address, telephone number and email, if available, of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to which the
application may be submitted. Although a Letter of Intent is not required, is
not binding, and does not enter into the review of subsequent applications,
the information that it contains allows NIH staff to estimate the potential
review workload and to plan the review.
The Letter of Intent is to be sent to Dr. Joel Breman at the address listed
under INQUIRIES by the Letter of Intent receipt date.
SCHEDULE
Letter of Intent Receipt Date: September 4, 2001
Application Receipt Date: October 26, 2001
Peer Review Date: February/March, 2002
Review by appropriate Board/Council: May, 2002
Earliest Anticipated Start Date: July, 2002
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, e-mail:
GrantsInfo@nih.gov. Applications are also available on the World Wide Web at
https://grants.nih.gov/grants/forms.htm.
Because we expect that there will not be any applications requesting less than
$250,000 in direct costs for each of the five years, applications should be in
the standard (non-modular) format with a detailed budget.
The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. Type the RFA
number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
Line 2 of the face page of the application form and the YES box must be
marked.
The sample RFA label available at
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies of the application in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
Additionally, at the time of submission, two additional copies of the
application must be sent to:
Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8326
Bethesda, MD 20892-8326
Rockville, MD 20852 (for express/courier service)
Applications must be received by October 26, 2001. If an application is
received after that date, it will be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. CSR
will also not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of previously
reviewed applications with substantial revisions. Such applications must
include an introduction addressing the previous critique.
Applicants are strongly encouraged to call the program contacts listed in
INQUIRIES with any questions regarding the responsiveness of their proposed
project to the goals of this RFA.
All clinical trials supported or performed by NIH require some form of
monitoring. The method and degree of monitoring should be commensurate with
the degree of risk involved in participation and the size and complexity of
the clinical trial. Monitoring exists on a continuum from monitoring by the
Principal Investigator/project manager or NIH program staff to a Data and
Safety Monitoring Board (DSMB). These monitoring activities are distinct from
the requirement for study review and approval by an Institutional Review Board
(IRB). For details about the Policy of the NIH for Data Safety Monitoring of
Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
For Phase I and II clinical trials, investigators must submit a general
description of the data and safety monitoring plan as part of the research
application. See NIH Guide Notice on “Further Guidance on a Data and Safety
Monitoring for Phase I and II Trials” for additional information:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NCI and the other sponsoring Institutes/Centers.
Incomplete and/or non-responsive applications will be returned to the
applicant without further consideration.
Applications that are complete and responsive to this RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities of the National Cancer
Institute in accordance with the review criteria stated below. As part of the
initial merit review, all applications will receive a written critique and
undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review,
will be discussed assigned a priority score, and receive a second level review
by the appropriate Board/Council.
Review Criteria
The nine criteria to be used in the evaluation of grant applications are
listed below.
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score, weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.
1. Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that drive
this field?
2. Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
3. Innovation: Does the project employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
4. Investigator: Is the investigator appropriately trained and well-suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
5. Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support? Is there evidence of the ability to sustain and utilize the research
and research training provided through the RFA, after the completion of the
grant period?
6. Research Capacity Building: Does the proposed program contribute to the
capacity of scientists and institutions in low- and middle-income nations to
perform research related to tobacco consumption? Does the proposed program
contain explicit strategies or plans to strengthen this capacity through
research training, career development, mentoring and other modes? Will
enhancement of specific departments in foreign institutions lead to overall
institutional excellence?
7. International Research Collaboration: In the course of research, will
collaborating foreign scientists and their institutions develop the capacity
to become independent investigators and national leaders in tobacco research
and public health intervention (i.e. develop their independently supported
research and capacity development programs and obtain financial support
nationally and internationally)? How will this occur?
8. Does the proposed project present special opportunities for furthering
research programs through the use of unusual talent, resources, populations,
or environmental conditions in other countries that are not readily available
in the U.S. or that augment existing U.S. resources?
9. Does the proposed project have specific relevance to the mission and
objectives of the sponsoring Institutes/Center and has the potential for
significantly advancing the health sciences in the U.S.?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
(a) The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Detailed plans for the recruitment and retention of subjects will
also be evaluated.
(b) The reasonableness of the proposed budget and duration in relation to the
proposed research.
(c) The adequacy of the proposed protections for human participants,
particularly the risks that may be posed to groups as well as individuals,
animals or the environment, to the extent they may be adversely affected by
the project proposed in the application.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review);
o Balance among projects to respond to the questions included in this RFA;
o Availability of funds;
o Programmatic priorities, including those of co-sponsoring institutions and
agencies;
o Geographic balance; and
o Potential to achieve a sustainable local and regional impact
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided indicating that inclusion
is inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines is available at
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.
The revisions relate to NIH defined Phase III clinical trials and require:
a) all applications or proposals and/or protocols to provide a description of
plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences. For studies
outside the U.S., the U.S. definitions of minorities do not apply. All
applicants should describe the racial/ethnic demographic profile(s) of the
proposed study population(s) and discuss the rationale for their selection.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling reasons not to include them. This
policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998. All investigators should describe the age range
of individuals involved in their proposed study, and describe the rationale
for their selection.
All investigators proposing research involving human subjects should read the
“NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects” that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may also obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
All investigators proposing research involving human subjects should read the
NIH policy on education in the protection of human research participants now
required for all investigators, which is published in the NIH Guide for Grants
and Contracts, June 5, 2000 (Revised August 25, 2000), available at the
following URL address:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
A continuing education program in the protection of human
participants in research is now available online at http://ohsr.od.nih.gov/.
For more information on NIH policies regarding human subjects see:
https://grants.nih.gov/grants/peer/hum_anim_notice.pdf and
https://grants.nih.gov/grants/peer/hs_review_inst.pdf.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at:
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this RFA (PA) in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA, International Tobacco and
Health Research and Capacity Building Program, is related to one or more
priority areas. Smoking is a major risk factor for heart disease, stroke,
lung cancer and other cancers - all leading causes of death. Smoking has
major and immediate effects during pregnancy and can lead to serious pediatric
disease. Smoking may also be associated with injuries and environmental
damage caused by fires. Adverse effects of environmental tobacco smoke (ETS)
include increased lower respiratory infection, increased respiratory symptoms,
reduced lung growth, exacerbation of asthma, irritation of the eyes, nose,
throat and lower respiratory tract, increased risk of middle-ear disease, and
increased risk of sudden infant death syndrome (SIDS). Potential applicants
may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.3 (FIC), 93.393 (NCI), 93.865, Research for Mothers and Children (NICHD),
93.3 (NINR), 93.279 (NIDA), 93.242 (NIMH). Awards are made under
authorization of Sections 301 and 405 and Title IV, Part A, as amended (42 USC
241, 284, and 287) of the Public Health Service Act as amended (42 USC 241 and
284) and administered under NIH grants policies and Federal Regulations 42 CFR
52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the
PHS mission to protect and advance the physical and mental health of the
American people.
REFERENCES
1..Johnson JG, Cohen P, Pine DS, et al. Association between cigarette smoking
and anxiety disorders during adolescence and early adulthood. JAMA 2000;
284: 2348-2351.
2. Lasser K, Boyd JW, Woolhandler S, et al. Smoking and mental illness, a
population-based prevalence study. JAMA 2000; 284: 2606-2610.
3. Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and
Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of
Health and Human Services. Public Health Service. June 2000.
4. Wewers ME, Ahijevych KL, Chen MS, et al. Tobacco use characteristics
among rural Ohio Appalachians. Journal of Community Health 2000; 25: 377-
388.
5. Barnum H, Greenberg RE. Cancers. In: Jamison DT, Mosely HW, Measham AR
et al. eds. Disease control priorities in developing countries. Washington,
DC. The World Bank. 1993.
6. Jha P, Chaloupka F. Curbing the epidemic: governments and the economics
of tobacco control . Washington, DC. The World Bank. 1999.